Abstract
BI-RADS 3 is an established assessment category in which the probability of malignancy is equal to or less than 2%. However, monitoring adherence to imaging criteria can be challenging and there are few established benchmarks for auditing BI-RADS 3 assignments. In this study, we explore some parameters that could serve as useful tools for quality control and clinical practice management. This retrospective study covered a 4-year period (Jan 2014-Dec 2017) and included all women over 40 years who were recalled from a screening exam and had an initial assignment of BI-RADS 3 (probably benign) category after diagnostic workup. A follow-up period of 2 years following the assignment of BI-RADS 3 was used for quantitative quality control metrics. Among 135,765 screening exams, 13,453 were recalled and 1,037 BI-RADS 3 cases met inclusion criteria. The follow-up rate at 24 months was 86.7%. The upgrade rate was 7.4% (77/1,037) [CI: 5.9-9.2%] and the PPV3 was 33.8% (26/77) [CI: 23.4-45.5%]. The cancer yield was 2.51% (26/1,037) [CI: 1.64-3.65%] and did not differ (p=0. 243) from the 2% probability of malignancy. The initial BI-RADS3 per screening exam and per recall from screening were 0.76% (1,037/135,765) [CI: 0.72-0.81%] and 7.7% (1,037/13,453) [CI: 7.26-8.17%], respectively. Regular audit of BIRADS 3 metrics has the potential to provide additional insights for clinical practice management. Data from varied clinical settings with input from an expert committee could help establish benchmarks for these metrics.
Highlights
Screening mammography is a vital element of breast cancer detection that has helped to reduce disease mortality [1-4]
In an effort to improve specificity, decrease cost, and reduce harm the American College of Radiology (ACR) established the Breast Imaging Reporting and Data System (BI-RADS) category 3 - probably benign designation to be used for short-term surveillance instead of immediate biopsy [8-10]
We introduce the following metrics while on surveillance and which may serve as useful benchmarks: (i) Percentage of initial BI-RADS 3 to total screens (ii) Percentage of initial BI-RADS 3 to screen-recalled cases (BIRADS 0)
Summary
Screening mammography is a vital element of breast cancer detection that has helped to reduce disease mortality [1-4]. With the current screening strategy, yearly cancer detection rate in the US is approximately five per 1000 screens and fewer than 2% of screens prove suspicious and require biopsy [5-7]. In an effort to improve specificity, decrease cost, and reduce harm the American College of Radiology (ACR) established the Breast Imaging Reporting and Data System (BI-RADS) category 3 - probably benign designation to be used for short-term surveillance instead of immediate biopsy [8-10]. The designation of BI-RADS 3 is made after an initial diagnostic work-up and should not be assigned on a screening mammogram. The assignment of BI-RADS 3 activates a short-term (6-, 12-, and 24-months) followup protocol which has been demonstrated to reduce false-positive findings at biopsy, while retaining a high sensitivity for earlystage breast cancer [9]
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